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DOCUMENTS

Practical Considerations for use of Certified EHRs for Clinical Research V1.0

The EHRCR Project (sponsored by the eClinical Forum) announces the document release:

Practical Considerations for Clinical Trial Sites using

Electronic Health Records (EHRs)

Certified for Clinical Research

Addressing Regulatory Considerations

Release 1.0 June, 2011

This is the first paper of its kind, speaking directly to clinical research investigative sites regarding the use of electronic health record systems. It is based on clinical research regulations and guidances and includes a checklist for sites to assess how their systems (whether certified or not), and their processes comply.

The EHRCR Project is comprised of members from pharmaceutical sponsors, CROs, software vendors (both CR and EHR), and has included regulatory review. They have produced an EHRCR Functional Profile which is now an ANSI/HL7 standard, approved by EuroRec, and is currently under consideration to become a CEN/ISO standard. The profile (a) is founded on current clinical research regulations / guidances, (b) translates requirements into measurable criteria to assess suitability of a system for clinical research, and (c) was used as a input for the recently released CCHIT Certified® 2011 Clinical Research certification option for Ambulatory EHRs.

The document describes a Functional Profile that identifies critical capabilities for the conduct of regulated clinical research utilizing EHR systems. Further to conforming to the EuroRec Repository Profiling Tools, this Profile identifies additional functionalities toward facilitating ease of use for those involved in clinical research.

This User Requirements document clarifies the minimum requirements to use healthcare systems as the data source for regulated clinical research1 today, in order to ensure the reliability of clinical research data from EHR (Electronic Health Record) systems.